Type 2 DiabetesNCT01136798

Impact of Exenatide on Sleep in Type 2 Diabetes

A study testing Exenatide in people with Type 2 Diabetes and Sleep Disordered Breathing, run by University of Chicago at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes, Sleep Disordered Breathing
What is being tested?: Exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 2 sitesUnited States
Study dates: 1 Jun 2010to 1 Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Who cannot join

Patients with unstable cardiac, neurological or psychiatric disease
Women who are pregnant or report trying to get pregnant will be excluded.
Patients treated for obstructive sleep apnea (OSA) will be excluded.
Patients with established OSA will be included only if they have declined treatment of OSA.
Patients with morbid obesity (BMI ≥ 40 gk/m2)
Patients on insulin

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Patients already taking an incretin-based drug will not be included
Patients with renal disease (creatinine clearance <30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
Patients taking an insulin secretagogue will be excluded.
Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The University of Chicago
Chicago, Illinois, 60637
University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study

The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.

Conditions: Type 2 Diabetes, Sleep Disordered Breathing
Being tested: Exenatide, Placebo
Keywords: slow wave sleep, exenatide and sleep
Medical subject headings: Diabetes Mellitus, Type 2, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExenatideDrug
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
PlaceboDrug
Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Study groups in NCT01136798
Study group	Role	What they receive
Usual T2 DM med regimen	Placebo comparator	Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks. Receives: Drug: Placebo
Usual T2 DM med regimen plus Exenatide	Experimental	Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide. Receives: Drug: Exenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-REM Slow Wave Sleep
Total minutes of non-REM sleep was measured
Measured: baseline and after 6 weeks of treatment
Total Amount of Slow Wave Activity
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
Measured: baseline and after 6 weeks of treatment

Secondary outcomes (4)

Sleep Efficiency During Polysomnographic Recording
Sleep efficiency will be calculated as total sleep time over total recording time.
Measured: baseline and after 6 weeks of treatment
Minutes of Wake After Sleep Onset During Sleep Recording
total amount of time spent awake after sleep onset and before morning awakening will be calculated
Measured: baseline and after 6 weeks of treatment
Severity of Obstructive Sleep Apnea
The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea.
Measured: baseline and after 6 weeks of treatment
Mean 24-h Blood Glucose Levels
Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.
Measured: baseline and after 6 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20101 Sep 2016

First posted3 Jun 2010 (estimated)
Study start1 Jun 2010
Primary completion1 Sep 2016
Study completion1 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01136798
Sponsor's protocol ID: 09-291-B
Status last verified: Aug 2018
First submitted: 13 Apr 2010
Last updated: 12 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study
ClinicalTrials.gov ID: NCT01136798
Acronym / sponsor ID: 09-291-B
Conditions: Type 2 Diabetes, Sleep Disordered Breathing
Keywords: slow wave sleep, exenatide and sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: 1 Jun 2010 (actual)
Primary completion: 1 Sep 2016 (actual)
Study completion: 1 Sep 2016 (actual)
First posted: 3 Jun 2010 (estimated)
Results: Posted 31 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual T2 DM med regimen	Placebo comparator	Drug: PlaceboSubjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Usual T2 DM med regimen plus Exenatide	Experimental	Drug: ExenatideSubjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

Key exclusion criteria (10 listed)

Patients with unstable cardiac, neurological or psychiatric disease
Women who are pregnant or report trying to get pregnant will be excluded.
Patients treated for obstructive sleep apnea (OSA) will be excluded.
Patients with established OSA will be included only if they have declined treatment of OSA.
Patients with morbid obesity (BMI ≥ 40 gk/m2)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExenatideExenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks	Drug	Usual T2 DM med regimen plus Exenatide
PlaceboExenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks	Drug	Usual T2 DM med regimen

Primary outcome

Non-REM Slow Wave Sleep
Time frame: baseline and after 6 weeks of treatment
Total minutes of non-REM sleep was measured
Total Amount of Slow Wave Activity
Time frame: baseline and after 6 weeks of treatment
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured

4 secondary outcomes

Sleep Efficiency During Polysomnographic Recording
Time frame: baseline and after 6 weeks of treatment
Minutes of Wake After Sleep Onset During Sleep Recording
Time frame: baseline and after 6 weeks of treatment
Severity of Obstructive Sleep Apnea
Time frame: baseline and after 6 weeks of treatment
Mean 24-h Blood Glucose Levels
Time frame: baseline and after 6 weeks of treatment

Results and safety

Results posted to the registry on 31 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual T2 DM Med Regimen	10	10
Usual T2 DM Med Regimen Plus Exenatide	8	8

Primary outcome: Non-REM Slow Wave Sleep

Time frame: baseline and after 6 weeks of treatment. Mean (Standard Deviation). Unit: minutes

Measure	Usual T2 DM Med Regimen n = 9	Usual T2 DM Med Regimen Plus Exenatide n = 7
Baseline	47.3 (37.3)	34.3 (34.4)
At 6 week	57.3 (38.1)	41.4 (40.3)

Population analysed: The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.

Primary outcome: Total Amount of Slow Wave Activity

Time frame: baseline and after 6 weeks of treatment

Population analysed: The second primary outcome measure, slow-wave activity (SWA) was not collected.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual T2 DM Med Regimen	0 of 10 (0%)	0 of 10 (0%)	Not reported
Usual T2 DM Med Regimen Plus Exenatide	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): When the investigators were unblinded in August 2016, a randomization error originating from the industry sponsor was identified, where only 8 participants were randomized to exenatide while 10 were randomized to placebo.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eve Van Cauter, PhD principal investigator

University of Chicago

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exenatide in people with Type 2 Diabetes and Sleep Disordered Breathing, run by University of Chicago at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-REM Slow Wave Sleep (time frame: baseline and after 6 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01136798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.